The present system relates to medical devices, and more particularly, to low-profile external fittings for systems that deliver materials to the interior of a body cavity.
Patients for which normal ingestion of food becomes difficult or impossible may require placement of a feeding tube to assist in providing their nutritional needs. For some individuals, such as comatose patients, stroke victims, or those with a compromised gastrointestinal tract and the like, this may require placement of a tube that is introduced percutaneously into the stomach for delivery of nutritional products directly into the stomach or jejunum. The procedure, known as a Percutaneous Endoscopic Gastrostomy (PEG) can be performed using several different techniques. Some techniques include the introduction of an endoscope into the stomach. The desired site where the stoma is to be created is indicated from above by depressing the abdomen and viewing the depressed site with the endoscope. Transillumination may also be utilized to locate the desired site through the abdominal wall. A sheathed needle or trocar punctures the abdominal wall and enters the stomach, creating a stoma. The needle is removed and a looped insertion wire/suture is introduced through the sheath where it is grasped by a snare or forceps deployed from the working channel of the endoscope. Once it is captured, the insertion wire/suture is pulled into the working channel of the endoscope. The endoscope is then withdrawn from the patient via the oral cavity, pulling the insertion wire/suture with it.
In the standard Ponsky method (or “pull” method), the distal loop of a percutaneous gastrostomy feeding tube is coupled to the insertion wire/suture exiting the patient's mouth. With the insertion wire/suture now tethered to the gastrostomy feeding tube, the endoscopist retracts the portion of the insertion wire/suture exiting the stoma, thereby pulling the gastrostomy feeding tube into the patient's mouth and towards the stomach. With continued retraction of the insertion wire/suture, the distal end of the gastrostomy feeding tube is pulled out through the stoma. The gastrostomy feeding tube typically includes a tapered dilator portion to aid its passage through the stoma. Once the feeding tube has been properly positioned with the proximal end cap or bolster of the feeding tube against the internal wall of the stomach, it is secured by an external bolster positioned against the outside of the abdomen wall.
In a variation of the PEG procedure known as the “push” method, the gastrostomy feeding tube is advanced or pushed down the esophagus by the physician and into position in the stomach using a wire guide that has been placed in the same manner as the insertion wire in the “pull” method. More specifically, the feeding tube is loaded on the portion of the wire guide exiting the patient's mouth by passing the end of the wire guide through a lumen extending through the length of the feeding tube. While holding the wire guide stationary, the physician pushes the feeding tube along the wire guide through the patient's mouth, into the stomach, and then out through the stoma. The feeding tube is then secured in the same manner as the “pull” method.
Yet another method is simply to insert the feeding tube through the patient's abdominal wall using the Seldinger technique and bypass insertion through the mouth. However, this method typically requires the deployment of an internal retention device including, and/or in addition to attaching a bolster to the interior portion of the feeding tube, which may need to be delivered and attached endoscopically.
As stated above, typically, a retention bolster is positioned against the inside and/or outside of the abdomen wall, or whichever body cavity or area the gastric port is being used in relation to. The bolster is present to keep in place and support the gastric port system and prevent sudden or unexpected removal of the tube from the stoma site. Bolsters for supporting tubes, such as feeding tubes, inside or outside the body have generally focused on maintaining the secure anchoring of the device to the patient. To provide support, bolsters have employed flanges, cross-bars, discs, or balloons for contacting the surface of the tissue. In the past, however, bolsters have tended to increase the localized pressure at the exit site, especially when the port or tube, either accidentally or intentionally, is moved thereabout.
For both ambulatory and bed-ridden patients, an external length of feeding tube and/or feeding apparatus may be connected to and removed from an external fitting of the tube, with or without an external bolster. Different diameters and lengths of tube may be needed. Depending on application, the system may need to be present with the patient for an extended period of time. Many current bolsters have a large and/or awkward profile such that extended use makes them uncomfortable for the patient where normal bodily movement is necessary.
A need therefore exists for a bolster that has a lower profile that is configured for use adjacent to a body surface that can decrease the localized pressure at the exit site, especially when the tube and/or bolster, either accidentally or intentionally, is moved thereabout.